Troublesome inconsistencies in the federal "regulation" of pyrethrin-based shampoos
Subject: Troublesome inconsistencies in the federal "regulation" of pyrethrin-based shampoos
Date: Thu, 8 Nov 2001 07:06:45 -0500
From: Stephen Tvedten <steve@getipm.com>
Organization: Get Set Inc. (www.getipm.com)
To: Paul Helliker <phelliker@cdpr.ca.gov>
Director, State of
California, Department of Pesticide Regulation
cc: Christine Whitman whitman.christine@epa.gov
Dear Mr. Helliker,
I thought you might like to read the following: http://www.ewjm.com/cgi/content/full/174/3/169
Troublesome inconsistencies in the federal regulation of
pyrethrin-based shampoos
Michael H Surgan 1
1 Environmental Protection Bureau New York State Attorney
General's Office 120 Broadway New York, NY 10271
michael.surgan@oag.state.ny.us
To the editor,
Sheldon Wagner's report1 of fatal asthma in a child after
use of a pyrethrin-based animal shampoo touches on several matters that bear
further clarification. Under current federal regulatory practices, the
Environmental Protection Agency (EPA) regulates various pyrethrin-containing
products used to control insect infestations on animals as well as other
pyrethrin-containing products applied to inanimate objects (eg, furniture and
carpets) for the same purpose. Shampoos intended for use by humans, however, may
have even higher concentrations of pyrethrins than the product involved in the
reported fatality and are regulated by the Food and Drug Administration (FDA).
The ways in which these products are regulated by the 2 agencies differ
significantly.
EPA regulations specifically prohibit any claim of safety
on the product label,2 and federal law limits the nature of claims made for a
pesticide "as a part of its distribution or sale."3 On the other hand,
the FDA's final regulatory review of over-the-counter(OTC) pediculicide products
includes a specific finding that theyare "safe," even though the
products must bear precautionary labeling.4 Thus, while manufacturers of
products intended for use on animals and inanimate objects cannot describe them
as "safe" or "nontoxic," manufacturers of OTC shampoos
intended for use on humans have claimed that they may be labeled as
"safe," citing the FDA document.
Using provisions of New York's General Business Law, which
prohibit deceptive advertising, the New York State Attorney General's office has
succeeded in eliminating false and misleading safety claims from the advertising
of well over 100 pesticide manufacturers and pest control services in the state
of New York. However, the dilemma
created by inconsistent EPA and FDA regulatory practices is apparent in 2 cases
we prosecuted recently. While each respondent agreed to cease and desist from
any safety claims for EPA- regulated sprays intended for use on pets and
inanimate objects, they asserted a right to make such claims on their OTC
shampoos for human use. They did, however, agree to accompany any such shampoo
advertising claims with disclaimers that the label contained important
health-related precautions.5 Because of jurisdictional limits, the advertising
restrictions we obtained are only enforceable in the state of New York, so it is
possible that OTC shampoos sold in other states carry safety claims without the
disclaimers required in New York.
Although the FDA allows label claims of safety provided the
specified precautions and other information are listed, acute allergic reactions
to pyrethrin insecticides may occur from the use of any of these products,
including those intended for use on humans. Physicians should know that these
reactions may occur and that labels that inform the choices of their patients
are subject to inconsistent regulations. Physicians should warn patients about
the potential consequences of the use of these products and be alert to the full
spectrum of potential sources and types of exposure.
References
1.Wagner, S. Fatal asthma in a child after use of an animal shampoo containing pyrethrin [letter]. West J Med 2000; 173: 86 -87.[Full Text]
2.Labeling Requirements for Pesticides and Devices. 40 CFR §156 (1996).
3.Federal Insecticide, Fungicide and Rodenticide Act, 7 USC §136.
4.Pediculicide drug products for over-the-counter human use; final monograph. 58 Federal Register 65452 (1993) (codified at 21 CFR §358).
5.Assurances of Discontinuance in the Matter of Pfizer Inc,
Respondent (in re: RID products) and in the Matter of Hogil Pharmaceutical Corp
(in re: A-200 products).
Well Mr. Helliker, it
certainly seems like safe and far more effective unregistered alternatives are
the answer. I know that the EPA has a full time librarian monitoring my
e-mails and web sites but, have you ever read my lice chapter from THE BEST
CONTROL found at: http://www.thebestcontrol.com ?
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